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Brain care study aims to shield diabetic seniors from memory decline

NCT ID NCT07250789

Knowledge-focused Sponsor: Steno Diabetes Center Copenhagen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how common memory problems are in older adults (65+) with type 2 diabetes. It then tests a program that combines several lifestyle changes to see if it can prevent or slow down memory loss. About 420 people will take part, and their thinking skills will be compared to those receiving usual care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for the Prevalence Study (Cognitive Screening): * Age ≥ 65 years * Diagnosis of Type 2 Diabetes (T2D) * Patient at the outpatient clinic at either Bispebjerg Hospital, Rigshospitalet, or Steno Diabetes Center Copenhagen * Speaks and understands Danish (required for the cognitive tests) * Informed written consent Inclusion Criteria for the Randomized Controlled Trial (Multidomain Intervention): * Meets all the above inclusion criteria, and at least one of the following: 1. A diabetes-specific dementia score ≥ 7 (equivalent to a 40% increased risk of developing dementia within the next 10 years), and a SCIP or MoCA score ≥ 0.5 SD below the age- and education-adjusted norm 2. A SCIP or MoCA score ≥ 1 SD below the age- and education-adjusted norm 3. At least 2 out of 5 SCIP subtests with a score ≥ 1 SD below the age- and education-adjusted norm Exclusion Criteria for the Prevalence Study (Cognitive Screening): * Diagnosis of dementia or prior referral to a dementia clinic * Diagnosis of psychiatric, neurological, or other disorders that, in the investigator's opinion, hinder participation in cognitive screening, preclude compliance with the study protocol, or affect the evaluation of results Exclusion Criteria for the Randomized Controlled Trial (Multidomain Intervention): * Meets all the above exclusion criteria * Participants whose cognitive MoCA screening indicates dementia will be excluded and advised to contact their physician * Participants unwilling to engage in parts of the multidomain intervention will be excluded

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive decline Cognitive impairment Diabetes Diabetes mellitus type 2 Type 2 diabetes Type 2 diabetes mellitus (T2DM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Endocrinology, Bispebjerg-Frederiksberg Hospital

    RECRUITING

    Copenhagen, 2400, Denmark

  • Department of Endocrinology, Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Steno Diabetes Center Copenhagen

    RECRUITING

    Herlev, 2730, Denmark

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